Study of Laparoscopic Radical Hysterectomy Based on Space Anatomy in Patients With IB3 and IIA2 Cervical Cancer

International Peace Maternity and Child Health Hospital

Status: Not yet enrolling

Conditions: Locally Advanced Cervical Cancer

Treatments: Procedure: Abdominal radical hysterectomy; Procedure: Laparoscopic radical hysterectomy based on space anatomy

Study type: Observational

Funder types: Other

Identifiers

NCT06759480

GKLW-A-2024-111-01

Details and patient eligibility

About

Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during surgery. Therefore, the exploration of effective and safe surgical treatments is crucial in enhancing the quality of life and prognosis for patients. Laparoscopic radical hysterectomy (LRH) offers the advantages of reduced bleeding and accelerated recovery, thereby minimizing patient discomfort and enhancing their quality of life. However, the prognosis of patients who received LRH or traditional abdominal radical hysterectomy (ARH) remains controversial. We proposed a modified LRH skill based on new space anatomy concept. In our previous single-center study, the result demonstrates that LRH based on space anatomy leads to less intraoperative blood loss and decreased ureteral injury rate compared with traditional skill. The benefits of this new method for patient survival remain uncertain. In this multicenter retrospective study, we aim to assess clinical prognosis and safety of this new LRH compared with traditional abdominal radical hysterectomy (ARH) in FIGO IB3 and IIA2 cervical cancer.

Enrollment: 500 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 20 to 70 years
2. Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;
3. Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;
4. no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement.

Exclusion criteria

1. patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;
2. pregnancy;
3. incomplete radical surgery;
4. follow-up time less than 6 months or lost to follow-up

Trial design

500 participants in 2 patient groups

LRH group

Description:

In this group, patients received a modified laparoscopic radical hysterectomy(LRH) based on space antomy.

Treatment:

Procedure: Laparoscopic radical hysterectomy based on space anatomy

ARH group

Description:

In this group, patients received a traditional abdominal radical hysterectomy(ARH). ARH group is defined as a control group.

Treatment:

Procedure: Abdominal radical hysterectomy